About this Medication

What the Medication is Used For

ARNUITY ELLIPTA is an inhaled corticosteroid used for the long-term treatment of asthma in people aged 12 years and older.

What it Does

ARNUITY ELLIPTA contains fluticasone furoate. Fluticasone furoate is an inhaled corticosteroid. It reduces inflammation in the airways of the lungs, which can ease breathing problems.

This medicine does not cure asthma but helps to prevent and control its symptoms.

When it Should not be Used

Do not use ARNUITY ELLIPTA:

To treat sudden symptoms of asthma.

ARNUITY ELLIPTAis not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler, such as salbutamol, during a sudden asthma attack.

If you are allergic to any of the medicinal or nonmedicinal ingredients contained in the product.

If you have a lactose or severe milk protein allergy.

If you are under 12 years of age.

What the Medicinal Ingredient Is

Fluticasone furoate.

What the Nonmedicinal Ingredients Are

Lactose monohydrate (which contains milk proteins).

What Dosage Forms it Comes In

Dry Powder for Oral Inhalation: 100 mcg and 200 mcg.

The dry powder is contained in a series of separate blisters and is delivered by the ELLIPTA inhaler.

Each inhaler contains 30 doses (one inhalation per day for 30 days).

If a sample is given to you by your doctor, it will contain 14 doses (one inhalation per day for 14 days).

Warnings and Precautions

BEFORE you use ARNUITY ELLIPTA talk to your doctor or pharmacist if you:

have liver disease, as you may be more likely to have side effects;

have weak bones (osteoporosis)

have eye problems such as glaucoma or cataracts

are pregnant or planning to become pregnant

are breastfeeding

have ever had thrush or a yeast infection in your mouth;

have ever had to stop taking another medication for your breathing problems because you were allergic to it or it caused problems;

have been taking other corticosteroids by mouth or inhalation;

have an immune system problem;

have ever had herpes simplex of the eye, a history of tuberculosis infections, or any type of viral, bacterial, fungal (yeast), or parasitic infection.

If you have moderate to severe liver problems, your doctor may do blood tests to monitor your liver function.

If you experience sudden shortness of breath or wheezing, or develop any other symptoms of an asthma attack, you should use your rapid onset, short duration, inhaled bronchodilator (e.g., salbutamol) and seek medical attention.

You should avoid coming into contact with people who have measles or chicken pox while taking ARNUITY ELLIPTA. If you are exposed, tell your doctor right away.

Drugs like ARNUITY ELLIPTA can cause Eye Disorders:

Cataracts: clouding of the lens in the eye, blurry vision, eye pain;

Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss;

You should therefore have regular eye exams.

Pregnancy

ARNUITY ELLIPTY is not usually recommended for use during pregnancy.

Before prescribing ARNUITY ELLIPT your doctor will consider the benefit to you and the risk to your unborn baby.

Breastfeeding/Lactation

It is not known whether the ingredients of ARNUITY ELLIPTA can pass into breast milk. If you are breast-feeding, check with your doctor before you take ARNUITY ELLIPTA.

Tell your doctor immediately if:

There is a change in your symptoms such as more coughing, attacks of wheezing, chest tightness, or an unusual increase in the severity of the breathlessness.

You wake up at night with chest tightness, wheezing or shortness of breath.

You are using increasing amounts of your rescue inhaler.

These could be warning signs that your condition may be worsening.

Interactions with This Medication

As with most medicines, interactions with other drugs
are possible. Tell your doctor, nurse, or pharmacist
about all the medicines you take, including drugs
prescribed by other doctors, vitamins, minerals, natural
supplements, or alternative medicines.

Drugs that may interact with ARNUITY ELLIPTA include:

Ketoconazole used to treat fungal infections;

Anti-HIV medicines;

Clarithromycin used to treat bacterial infections;

Any other corticosteroid medicines.

Proper Use of This Medication

ARNUITY ELLIPTA does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

Your doctor will determine the dose of ARNUITY ELLIPTA based on the severity of your asthma and if you have liver disease.

It is important to continue using ARNUITY ELLIPTA even if you do not have any symptoms.

Do not stop taking ARNUITY ELLIPTA without talking to your doctor.

Take ARNUITY ELLIPTA:

exactly as prescribed;

every day;

every 24 hours, at about the same time each day.

Rinse your mouth with water after each inhalation. Do not swallow the water.

Usual Dose

One inhalation through the mouth once a day.

If you have severe asthma, your doctor may decide that you should use the higher strength of ARNUITY ELLIPTA (200 mcg).

If you have liver disease, your doctor may decide that you should use the lower strength of ARNUITY ELLIPTA (l00 mcg).

Do not take more that the recommended dose.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you have taken larger doses than instructed for a long period of time, you should ask your doctor or pharmacist for advice.

Missed Dose

If you miss a dose, carry on and take your next dose at the usual time the next day. Do not take an extra dose to make up for the missed one.

About your ARNUITY ELLIPTA Inhaler

The ELLIPTA inhaler is packaged in a tray, with a peelable foil lid. Do not remove the foil until you areready to use the inhaler. Peel back the lid to open the tray.

In the tray, you will find a small sachet containing a drying agent to prevent moisture from forming inside the tray. Once you have opened the lid of the tray, throw away the sachet. It is dangerous to eat or inhale the contents of the sachet, so keep it away from children and pets.

ARNUITY ELLIPTA expires 6 weeks after you have opened the lid of the tray.

The plastic ELLIPTA inhaler has a light grey body, an orange mouthpiece cover, and a dose counter. The mouthpiece and the air vent are hidden by the cover and can only be seen when the cover is opened.

The ELLIPTA inhaler is a ready-to-use device. You will not need to prime it before using it for the first time.

Please follow the instructions ‘OPEN, INHALE, and CLOSE’ to use your ELLIPTA inhaler. The instructions shown below apply to both the 30-dose and 14-dose ELLIPTA inhaler.

Open

How to activate the ELLIPTA Inhaler for use:

Do not shake the ELLIPTA inhaler at any point during use as this is not necessary.

When you take your ELLIPTA inhaler out of its tray it will be in the closed position.

Keep the cover closed until you are ready to inhale a dose.

When you are ready, slide the orange cover to the side until you hear a ‘click’.

The dose counter will now count down by one number. This shows that the dose is ready to inhale. If the dose counter does not count down asyou hear the ‘click’, the inhaler will not deliver the If this occurs, take it back to your pharmacist for advice.

You are now ready to inhale a dose.

Inhale

How to take the medication:

Sit down or stand in a comfortable position.

While holding the inhaler away from your mouth, exhale a complete breath (i.e. breathe out as far as is comfortable). Do not breathe out into the inhaler.

Put the mouthpiece between your lips, and close your lips firmly around it. Do not block the airvent with your fingers or the inhaler mouthpiece with your teeth.

Take one long, steady, deep breath in. Hold this breath for as long as possible (minimum 3-4 seconds).

Remove the inhaler from your mouth.

Exhale slowly and gently.

Continue to breathe normally.

Rinse your mouth with water. Do not swallow.

You may not be able to taste or feel the medicine, even when you are using the inhaler correctly.

How to clean the ELLIPTA Inhaler

You can clean the mouthpiece of the inhaler with a clean dry tissue after you have inhaled the medicine.

Close

How to close the ELLIPTA Inhaler

Once you have cleaned the ELLIPTA inhaler you should slide the cover upwards as far as it will go to cover the mouthpiece.

Important

Only open the ELLIPTA inhaler when you are ready to take a dose. If you open and close the cover of the

ELLIPTA inhaler without inhaling the medicine, you will lose the dose. It is not possible to accidently take extra medicine or a double dose in one inhalation.

When fewer than 10 doses are left, half of the dose counter shows red, to remind you to refill your prescription. After you have used the last dose, half ofthe dose counter shows red and the number 0 is displayed. Your inhaler is now empty. If you open the cover after this, the dose counter will change from half red to completely red.

Discard the inhaler 6 weeks after opening the moisture-protective foil tray or when the counter reads “0”, whichever comes first.

Never try to alter the numbers on the counter or detach the counter on the front of the ELLIPTA inhaler. The counter cannot be reset and is permanently attached to the inhaler.

Side Effects and What to do About Them

Side effects may include:

Sore, raised patches in the mouth or throat caused by a yeast infection (candidiasis/thrush). After using ARNUITY ELLIPTA, rinse your mouth out with water immediately (Do not swallow) as it may help stop this side effect from occurring.

Infection or inflammation of the nose or throat

Infection or inflammation of the sinuses (sinusitis)

Pain and irritation in the back of the mouth and throat

Headache

Back pain

Cough

Hoarseness and voice changes

Respiratory tract infection

Stomach pain and diarrhea

If any of these affects you severely, tell your doctor, nurse or pharmacist.

Serious Side Effects, how Often they
Happen and What to do About Them

Symptom / effect

Talk with your doctor or pharmacist

Stop taking drug and call your doctor or pharmacist

Only if severe

In all cases

Common

Thrush (yeast
infection):White patches
in the mouth
and on the
tongue, sore
throat

Bone
Fractures or
Osteoporosis:In situations
where healthy
people would
not normally
break a bone
you may have
sudden pain in
any location
and especially
in the wrist,
spine or hip.
This may be a
fracture.

✓

This is not a complete list of side effects. For any unexpected effects while taking ARNUITY ELLIPTA contact your doctor or pharmacist.

How to Store it

Keep out of the reach and sight of children. Your medicine may harm them.

Keep your inhaler in a cool dry place away from direct heat or sunlight. Keep it closed when not in

use.

Do not store ARNUITY ELLIPTA above 25°C.

ARNUITY ELLIPTA expires 6 weeks after you have opened the lid of the tray.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance
Program by one of the following 3 ways:

Postage paid labels, Canada Vigilance Reporting
Form and the adverse reaction reporting
guidelines are available on the MedEffect Canada
Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the
management of side effects, contact your health professional.
The Canada Vigilance Program does not provide medical
advice.

More Information

You may need to read this package insert again. Pleasedo not throw it away until you have finished your medicine. This document plus the full product monograph, prepared for health professionals can be found at: